Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis

Official Title: “The Effect of Teriparatide Compared With Risedronate on Back Pain in Postmenopausal Women With Osteoporotic Vertebral Fractures”

The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in women with osteoporosis who have chronic back pain due to a spinal bone fracture.

Intervention(s) in this Clinical Trial

• Drug: teriparatide
  • 20 ug/day, subcutaneous, 18 months
• Drug: risedronate
  • 35 mg/once weekly, oral, 18 months
• Drug: placebo
  • once weekly, oral, 18 months
• Drug: placebo
  • daily, subcutaneous, 18 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Teriparatide
  • Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
• Active Comparator: Risedronate
  • Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Primary Measures

• Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint
  • Time Frame: 6 Months
    Safety Issue?: No

Secondary Measures

• Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint
  • Time Frame: 12 Months
    Safety Issue?: No
• Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint
  • Time Frame: 6 Months
    Safety Issue?: No
• Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint
  • Time Frame: 12 Months
    Safety Issue?: No
• Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
  • Time Frame: Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
    Safety Issue?: No
• Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
  • Time Frame: Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
    Safety Issue?: No
• Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months
  • Time Frame: Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
    Safety Issue?: No
• Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months
  • Time Frame: Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
    Safety Issue?: No
• Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.
  • Time Frame: Baseline, 3 Months
    Safety Issue?: No
• Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.
  • Time Frame: Baseline, 6 Months
    Safety Issue?: No
• Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.
  • Time Frame: Baseline, 12 Months
    Safety Issue?: No
• Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
  • Time Frame: Baseline, 6 Months
    Safety Issue?: No
• Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
  • Time Frame: Baseline, 12 Months
    Safety Issue?: No
• Number of Participants With Adverse Events (Safety) During 12 Months
  • Time Frame: Baseline through 12 Months
    Safety Issue?: Yes
• Number of Participants With Adverse Events (Safety) During 18 Months
  • Time Frame: Baseline through 18 Months
    Safety Issue?: Yes
• Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint
  • Time Frame: 18 Months
    Safety Issue?: No
• Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint
  • Time Frame: 18 Months
    Safety Issue?: No
• Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months
  • Time Frame: Baseline through 18 Months
    Safety Issue?: No
• Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months
  • Time Frame: Baseline through 18 Months
    Safety Issue?: No
• Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.
  • Time Frame: Baseline, 18 Months
    Safety Issue?: No
• Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
  • Time Frame: Baseline, 18 Months
    Safety Issue?: No

Inclusion Criteria:

• Postmenopausal women 45 years or older. No period for at least two years.
• History of back pain that started at least 2 months prior to the initial visit (likely due to spinal bone fracture determined by investigator).
• Minimum of one moderate spinal bone fracture.
• Beginning pain level of at least four on an eleven point scale.
• Bone Mineral Density (BMD) must meet criteria
• Able to read, understand, and administer self-questionnaires.
• Be willing and able to use a pen-injector to deliver the medication.

Exclusion Criteria:

• Are at increased risk for osteosarcoma.
• Have an active or suspected diseases that affects bone metabolism other than osteoporosis.
• Participants that already know that they will require procedures to repair their spinal bone fractures.
• Abnormal values of certain lab tests.
• Anything that would make it difficult to determine if the back pain was due to the fracture.
• Poor medical or psychiatric condition.
• Alcohol or drug abuse within a year of the study start.
• Certain malignant neoplasms in the 5 years prior to enrollment.
• Active liver disease or clinical jaundice.
• Significantly impaired renal function.
• History of nephrolithiasis or urolithiasis within 2 years prior to enrollment.
• Known contraindication or intolerance to risedronate and/or teriparatide therapy.
• Treatment with oral strontium or certain therapeutic doses of fluoride.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Eli Lilly and Company Industry

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT -5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00343252

Study ID Number: 9041

ClinicalTrials.gov Identifier: NCT00343252

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry